GUEST COLUMNISTS

  • 4 (More) Critical Considerations For Drug Delivery Device Development
    4 (More) Critical Considerations For Drug Delivery Device Development

    Today, injection devices are a staple among biologic and other pharmaceutical products. With the exception of oncology products, the majority of biologic products today are launched as some form of combination product, which are stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.

  • MDSAP — History and Advantages
    MDSAP — History and Advantages

    The Medical Device Single Audit Program (MDSAP) has worked out its kinks and is poised for exponential growth, but it may be a while before the initiative makes headway in the EU and China.

  • What Organizational Design Says About Your Commitment To Data Integrity
    What Organizational Design Says About Your Commitment To Data Integrity

    Understanding how to be appropriately staffed and being prepared to explain any perception of inequity could mean the difference between success and failure of appropriate data integrity in both regulatory compliance and product support.

  • 3 Critical Areas To Review In Strategic Site Selection
    3 Critical Areas To Review In Strategic Site Selection

    Have you ever put off doing something you knew needed to be done, even though you had the ability and money for it?  Think exercising, getting a will or going to the dentist (hopefully you have dealt with at least the latter).  In the same way, many study sponsors put off aggregating and utilizing key intelligence on their previously used investigator sites for use in future strategic site selections. At times, there will be unique reasons for engaging with a certain investigator site or the need to use research-naive sites. However, if previously used sites will be considered for a new study, it is vital to review some key information for a truly strategic site selection process.  Let's take a look at some of these key, yet often forgotten, areas.

  • Asia Bioprocessing Capacity Trends: Overall Growth, But Cell Therapy Shortages Loom
    Asia Bioprocessing Capacity Trends: Overall Growth, But Cell Therapy Shortages Loom

    Overall, the growth in Asia’s bioprocessing capacity, particularly in China, has been impressive, albeit from a low baseline. Capacity growth over the past five years has been over 20 percent annually. New facility construction and expansions reflect the demand for biologics for domestic consumption, while other facilities are beginning to develop manufacturing strategies for GMP production for major markets, with capacity involving commercial-scale stainless steel and single-use bioreactors.

  • Does A Phase 1 Virtual Biopharma Company Need A cGMP Quality System?
    Does A Phase 1 Virtual Biopharma Company Need A cGMP Quality System?

    Virtual pharmaceutical/biotech companies often receive conflicting advice regarding the need to establish an internal cGMP quality system. Either they’re told “you need an extensive set of cGMP SOPs” or “you don’t need any cGMP SOPs at all.” Which advice is correct?

  • U.S. Bone Repair Devices: Trochanteric Grip Market Stalls, Cerclage Cables Take Off
    U.S. Bone Repair Devices: Trochanteric Grip Market Stalls, Cerclage Cables Take Off

    Approximately 75,000 procedures were completed in 2018 using cerclage cables and trochanteric grips, devices used in the repair of broken or surgically altered bones. This procedure volume is increasing every year.

  • Standard Of Care And The Internet Of Medical Things
    Standard Of Care And The Internet Of Medical Things

    During the American College of Cardiology annual meeting in March, researchers from Stanford University, Apple Inc., and other academic centers unveiled the Apple Heart Study, a first-of-its-kind large-scale study involving more than 400,000 members of the general population (iPhone and Apple Watch owners). The goal of the study was to identify users with a potentially lethal irregular heart rhythm called atrial fibrillation (AF).

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PHARMA OUTSOURCING WHITE PAPERS

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OUTSOURCED PHARMA CONTENT COLLECTIONS

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Are we dangerously reliant on outsourcing to China, and is this outsourcing without the good of U.S. patients in mind? Our drug development and manufacturing outsourcing industry can’t escape the ins-and-outs of geopolitical and global affairs. Learn more in this free collection of articles

OUTSOURCING EVENTS

Lyophilization - An Introduction to the Scientific Principles August 27 - 27, 2019
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Straight to the Point: Reaching Clinical Stage Development with a CHOZN® Cell Line August 29, 2019
Time: 11:00 AM Eastern Daylight Time. Duration 1 Hour
Time:  11:00 AM Eastern Daylight Time
Duration:  1 Hour
Authoring and Implementing Standard Operating Procedures (SOPs): Best Practices for Success September 4 - 4, 2019
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
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